Anterior Cruciate Ligament RuptureFCACLRNCT05487768
Functional Connectivity After Anterior Cruciate Ligament Reconstruction
A study testing EEG measurement in people with Anterior Cruciate Ligament Rupture and Electroencephalography, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Background: Despite surgical reconstruction and rehabilitation, individuals after a primary anterior cruciate ligament injury have a significantly increased risk of relapse. The mechanisms for this increased risk may go beyond mere physiological and biomechanical changes of the reconstructed anterior cruciate… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Electroencephalography, Injuries
- What is being tested?
- EEG measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Sep 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Older than 18 years of age.
- Primary anterior cruciate ligament rupture and reconstruction
- Older than 18 years of age.
Who cannot join
- Major knee surgery in the past.
- Diagnosed with any knee pathology at this moment.
- Have any muscle or nerve related conditions that affect the functioning of the lower limbs.
- CONTROL GROUP
- Major knee surgery in the past.
- Diagnosed with any knee pathology at this moment.
- Have any muscle or nerve related conditions that affect the functioning of the lower limbs.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Despite surgical reconstruction and rehabilitation, individuals after a primary anterior cruciate ligament injury have a significantly increased risk of relapse. The mechanisms for this increased risk may go beyond mere physiological and biomechanical changes of the reconstructed anterior cruciate ligament. The loss of ligamentous mechanoreceptors can affect sensory feedback and consequently result in a disrupted afferent input to the central nervous system. However, research on the neuroplasticity of the central nervous system after anterior cruciate ligament injury and more specifically on the cooperation between different brain areas (=functional connectivity) in motor execution and performance is limited.
Read more
Research purpose:
To investigate the changes in terms of functional connectivity in the brain after sustaining an anterior cruciate ligament injury and associated reconstruction?
Population:
- Patients after anterior cruciate ligament reconstruction
- Healthy controls
Protocol:
First, all participants are required to complete several questionnaires regarding the level of anxiety and the functioning of the knee in daily activities and sports. In addition, during the baseline testing, participants will be required to perform an experiment while electrical brain activity is recorded by means of an electroencephalography (EEG) measurement. During this experiment, the participants will have to successively perform the following exercises: 10x knee extension from sitting (left and right), 10x bipodal squat from standing, 5x 30 seconds unipodal standing (left and right).
The above protocol will be administered to the patient group for the first time 8 weeks after the anterior cruciate ligament reconstruction. When the patients do not need further rehabilitation, they will be invited a second time to execute the same protocol again. The control group will only have to carry out the above protocol once.
Finally, for one year after the last test, the patient group will be contacted monthly to monitor return to sport and the occurrence of injuries.
- Being tested
- EEG measurement
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG measurementOther
EEG measurement to evaluate functional connectivity in the brain during 3 motor tasks:
- Knee extension while sitting (10x left - right)
- Bipodal squatting (10x)
- Unipodal stance (5x30 seconds left-right)
| Study group | Role | What they receive |
|---|---|---|
| Anterior cruciate ligament reconstruction group | Experimental | Patients that underwent an anterior cruciate ligament reconstruction Receives: Other: EEG measurement |
| Control group | Active comparator | Healthy matched controls Receives: Other: EEG measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction
Electroencephalography (EEG) will be recorded from a 128 Sn surface electrode cap during 3 motor tasks. Functional connectivity will be analyzed.
Measured: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Secondary outcomes (6)
Change in subjective knee functionality measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire
Assess the patients opinion about their knee and associated problems. Each item is given a score between 0 and 4, then the total score is converted to a scale of 0-100. A higher score indicates less disfunction.
Measured: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in kinesiophobia measured by the Tampa scale of Kinesiophobia (TSK) - Questionnaire
This questionnaire consists of 17 questions and evaluates the extent to which patients experience kinesiophobia.
Each item is given a score between 0 and 4. A higher score indicates more kinesiophobia.
Measured: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in knee confidence - Questionnaire
To evaluate the confidence of patients in their operated knee, expressed as a percentage relative to the nonoperated side (0-100%). A lower score indicates less confidence.
Measured: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in worrying behaviour measured by the Penn State Worry Questionnaire (PSWQ) - Questionnaire
This questionnaire consists of 16 questions and evaluates the extent to which patients are concerned
Each item is given a score between 1 and 5. The total scores range from 16 to 80 with higher scores indicative of higher levels of trait worry.
Measured: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in athletes' emotion, confidence, and risk appraisal when returning to sports after an anterior cruciate ligament reconstruction measured by the ACL-Return to sport after injury (ACL-RSI) - Questionnaire
This questionnaire consists of 12 questions divided into three main sections: athletes' emotion, confidence, and risk assessment when returning to sport after an ACL injury and/or reconstructive surgery.
Each item is given a score between 0 and 100, after which the total score is converted to a scale of 0-100. A lower score indicates more concerns about return to sport.
Measured: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Follow up questionnaire
To monitor return to sport and injury occurence in the patient group
Measured: Monthly, for one year after the end of the rehabilitation (on average 9-12 months postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start23 Sep 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Erik Witvrouw, Prof. Dr., Principal investigator, Department of Rehabilitation Sciences, Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487768
- Sponsor's protocol ID
- ONZ-2022-0231
- Acronym
- FCACLR
- Status last verified
- Sep 2024
- First submitted
- 27 Jul 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Connectivity After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05487768
- Acronym / sponsor ID
- FCACLR / ONZ-2022-0231
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Despite surgical reconstruction and rehabilitation, individuals after a primary anterior cruciate ligament injury have a significantly increased risk of relapse. The mechanisms for this increased risk may go beyond mere physiological and biomechanical changes of the reconstructed anterior cruciate ligament. The loss of ligamentous mechanoreceptors can affect sensory feedback and consequently result in a disrupted afferent input to the central nervous system. However, research on the neuroplasticity of the central nervous system after anterior cruciate ligament injury and more specifically on the cooperation between different brain areas (=functional connectivity) in motor execution and performance is limited.
Research purpose:
To investigate the changes in terms of functional connectivity in the brain after sustaining an anterior cruciate ligament injury and associated reconstruction?
Population:
- Patients after anterior cruciate ligament reconstruction
- Healthy controls
Protocol:
First, all participants are required to complete several questionnaires regarding the level of anxiety and the functioning of the knee in daily activities and sports. In addition, during the baseline testing, participants will be required to perform an experiment while electrical brain activity is recorded by means of an electroencephalography (EEG) measurement. During this experiment, the participants will have to successively perform the following exercises: 10x knee extension from sitting (left and right), 10x bipodal squat from standing, 5x 30 seconds unipodal standing (left and right).
The above protocol will be administered to the patient group for the first time 8 weeks after the anterior cruciate ligament reconstruction. When the patients do not need further rehabilitation, they will be invited a second time to execute the same protocol again. The control group will only have to carry out the above protocol once.
Finally, for one year after the last test, the patient group will be contacted monthly to monitor return to sport and the occurrence of injuries.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior cruciate ligament reconstruction group | Experimental | Other: EEG measurementPatients that underwent an anterior cruciate ligament reconstruction |
| Control group | Active comparator | Other: EEG measurementHealthy matched controls |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Older than 18 years of age.
- Primary anterior cruciate ligament rupture and reconstruction
- Older than 18 years of age.
Key exclusion criteria (7 listed)
- Major knee surgery in the past.
- Diagnosed with any knee pathology at this moment.
- Have any muscle or nerve related conditions that affect the functioning of the lower limbs.
- CONTROL GROUP
- Major knee surgery in the past.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG measurementEEG measurement to evaluate functional connectivity in the brain during 3 motor tasks: * Knee extension while sitting (10x left - right) * Bipodal squatting (10x) * Unipodal stance (5x30 seconds left-right) | Other | Anterior cruciate ligament reconstruction group, Control group |
Primary outcome
Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction
Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Electroencephalography (EEG) will be recorded from a 128 Sn surface electrode cap during 3 motor tasks. Functional connectivity will be analyzed.
6 secondary outcomes
Change in subjective knee functionality measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire
Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in kinesiophobia measured by the Tampa scale of Kinesiophobia (TSK) - Questionnaire
Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in knee confidence - Questionnaire
Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in worrying behaviour measured by the Penn State Worry Questionnaire (PSWQ) - Questionnaire
Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in athletes' emotion, confidence, and risk appraisal when returning to sports after an anterior cruciate ligament reconstruction measured by the ACL-Return to sport after injury (ACL-RSI) - Questionnaire
Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Follow up questionnaire
Time frame: Monthly, for one year after the end of the rehabilitation (on average 9-12 months postoperative).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Witvrouw, Prof. Dr. principal investigator
Department of Rehabilitation Sciences, Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG measurement in people with Anterior Cruciate Ligament Rupture and Electroencephalography, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction (time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.